NDAINHALATIONPOWDER
Approved
Mar 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
6/8 — Strong
TOBI PODHALER (tobramycin) by Viatris is clinical pharmacology: corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. First approved in 2013.
Drug data last refreshed 48m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOBI PODHALER is an inhalation powder formulation of tobramycin, an aminoglycoside antibiotic indicated for chronic respiratory tract infections in cystic fibrosis patients. The drug works by inhibiting bacterial protein synthesis in susceptible gram-negative organisms, particularly Pseudomonas aeruginosa, a common CF pathogen. It delivers high local lung concentrations while minimizing systemic exposure through the pulmonary route.
$0.011BPart D
Peak4.1 years to LOEProduct is in peak commercial phase with modest Part D utilization ($11M annually), suggesting a stable but niche market requiring specialized commercial focus within rare respiratory disease channels.
Mechanism of Action
CLINICAL PHARMACOLOGY: Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be…
Pharmacologic Class:
Aminoglycoside Antibacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Tobramycin Injection to Prevent Infection in Open Fractures
Started Jan 2022
600 enrolled
Wound InfectionFractures, OpenSurgical Site Infection
Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
Started Oct 2018
15 enrolled
Prosthetic Joint Infection
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
Started Jun 2018
47 enrolled
Cystic Fibrosis
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
Started Jul 2017
35 enrolled
Ototoxicity
Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection
Started Feb 2017
107 enrolled
Non-cystic Fibrosis Bronchiectasis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.